Identity
- Trade Name
- TempoLok NE Cement 118g cartridge, 50 mixing tips FDA UDI
- Generic Name
- Zinc oxide eugenol dental cement FDA UDI
- Device Name
- The TempoLok™ Automix NE refill includes: one double cartridge (118 g) non-eugenol, zinc oxide cement and 50 mixing tips. This product is used for temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges and inlays. They can also be used as a securely sealing protective cover for preparations to be restored later. FDA UDI
- Model / Reference
- 220282 FDA UDI
- Description
- The TempoLok™ Automix NE refill includes: one double cartridge (118 g) non-eugenol, zinc oxide cement and 50 mixing tips. This product is used for temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges and inlays. They can also be used as a securely sealing protective cover for preparations to be restored later. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549100475 FDA UDI
- 510(k) Number
- K984340 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Zinc oxide eugenol dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
TempoLok NE Cement 118g cartridge, 50 mixing tips by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K984340 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 3269aff1-f8b4-42e4-a613-0bbcb2877f0a 36 fields · synced Jun 6, 2026